Premier Zinc

Manufacturer
ENSO SKINCARE & WELLNESS LLC | Custom Analytics LLC | Fragrance Manufacturing Inc. | Fallien Cosmeceuticals Ltd.
Effective date
2025-12-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:26:14

Label at a glance#

ProductPremier Zinc
Active ingredientZINC OXIDE
Label structure9 sections

Indications and uses

Helps Prevent Sunburn. If used as directed with other sun protection measures (see “Directions”), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

Apply liberally 15 minutes before sun exposure. Use a water-resistant product if swimming or sweating. Reapply at least every 2 hours. Children under 6 months: Ask a doctor. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad-Spectrum SPF value of 15 or higher and other sun protection measures inclu...

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 20%

Purpose:

OTC - PURPOSE SECTION

Sunscreen

Uses:

INDICATIONS & USAGE SECTION

Helps Prevent Sunburn. If used as directed with other sun protection measures (see “Directions”), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings:

WARNINGS SECTION

For external use only. Do not use on broken or damaged skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Warnings:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Directions:

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure. Use a water-resistant product if swimming or sweating. Reapply at least every 2 hours. Children under 6 months: Ask a doctor. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad-Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. - 2 p.m. Wear long-sleeved shirts, pants, hats and sunglasses.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Hydrogen Dimethicone, Microcrystalline Wax, PEG-10 Dimethicone, PEG-30 Dipolyhydroxystearate, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, Water

Other Information:

OTHER SAFETY INFORMATION

  • Protect this product from excessive heat and direct sun

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130385971205044GTIN-13: 0385971205044
EAN-13: 0385971205044
GTIN-12: 385971205044
UPC-A: 385971205044
GTIN storage (14 digits): 00385971205044
Enso 205.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85971-205-04Premier Zinc113 g in 1 BOTTLE, PUMPCREAM1132

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85971-20585971-205-04
58892-205

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Premier ZincZINC OXIDEENSO SKINCARE & WELLNESS LLC3bb378c8-14b0-aa13-e063-6294a90a4db32025-12-17WarningsExact identifier
ndc (package): 85971-205-04
ndc (product): 85971-205
ndc11 (package): 85971020504
spl id: 46283ee6-774b-ee88-e063-6294a90ae032
spl set id: 3bb378c8-14b0-aa13-e063-6294a90a4db3
Proceuticals Private Label by TiZO non-tinted mineral sunscreen 20% zinc oxideZINC OXIDEFallien Cosmeceuticals, Ltd1bbd14ec-4240-f0c2-e063-6394a90a2c072024-06-25WarningsExact identifier
ndc (product): 58892-205

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.